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Clinical Trials/NCT02186639
NCT02186639CompletedNot Applicable

Exhaled Breath Analysis in Patients With COPD by Secondary Electrospray Ionization - Mass Spectrometry (SESI-MS)

University of Zurich1 site in 1 country40 target enrollmentStarted: June 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
COPD-specific mass spectrometric exhaled breath pattern

Study Overview

Brief Summary

To answer the question whether a disease specific profile of breath in patients with COPD can be detected by an untargeted metabolomic study using exhaled breath analysis by mass spectrometry.

Detailed Description

This is an observational study comparing the volatile organic compounds (VOCs) in exhaled breath between COPD patients and matched control subjects (age, gender, smoking-state). 40 COPD patients (20 non-frequent, 20 frequent exacerbators) and 40 matched controls will be examined by SESI-MS on the composition of exhaled breath for identification of COPD specific markers.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • confirmed COPD GOLD stage I-IV, based on a post-bronchodilator spirometry (FEV1/FVC < 0.7) performed within the last 6 months
  • age between 18 and 80 years at study entry
  • healthy controls: normal spirometry

Exclusion Criteria

  • COPD exacerbation within the last 6 weeks
  • any lung disease other than COPD
  • acute inflammatory disease (e.g. common cold) within the last 6 weeks
  • acute or chronic hepatic disease
  • renal failure or renal replacement therapy

Outcomes

Primary Outcomes

COPD-specific mass spectrometric exhaled breath pattern

Time Frame: baseline

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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